Pharmacogenomic Testing for Medication Management
Conditions
Brief summary
Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known with genetic variation.
Detailed description
Pharmocogenomic. A multicenter, observational study to evaluate the use of a Pharmocogenomic test assessment in the medication regimen and disease management for patients under drugs known to be influenced by genetic variation.
Interventions
None listed
Sponsors
ClinLogic LLC
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients may be included in the Study if they meet all of the following inclusion criteria: 1. Male or female patients of 25 years of age or older who are able to give their written Informed Consent to participate in a Clinical Study based on voluntary agreement with a thorough explanation of the patient's participation will be provided to them. 2. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 120 days (index PGx test assessment); 3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the (index PGx test assessment), including over-the- counter medications; 4. Patient has a history of at least one TDAE over the 24-month period preceding the PGx test assessment, or has experienced inadequate efficacy from a target drug.
Exclusion criteria
Patients will be excluded from the Study if any of the following criteria apply: 1. Patient is currently hospitalized; 2. Patient's medical and medication history is unavailable over the 120-day period preceding the PGx test assessment; 3. Patient is unable to provide an accurate history due to mental Incapacity; 4. Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radar, Pharmocogenomic | The period of enrollment is anticipated to be 36 months with a 120- day follow-up period, for total study duration of approximately 40 months from first patient enrolled to completion of follow-up on the last patient in. | The primary endpoint of the study is the binary occurrence of meaningful change in drug regimen, defined in each patient when: 1. A genotype known to affect a drug the patient is taking is identified, \*and\* 2. The patient's treating physician makes at least one target drug regimen change, dose, substitution, or discontinuation. Change in drug dose, substitution, or discontinuation among patients with an identified genotype known to affect a drug the patient is taking as directed. This will be assessed by a quantitative survey. |
Countries
United States
Contacts
Primary ContactDiana Messir
Backup ContactDiana M Messir
Outcome results
None listed